CN116235041A - Test strip box, monitoring equipment and method for manufacturing test strip box - Google Patents

Test strip box, monitoring equipment and method for manufacturing test strip box Download PDF

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Publication number
CN116235041A
CN116235041A CN202180066990.7A CN202180066990A CN116235041A CN 116235041 A CN116235041 A CN 116235041A CN 202180066990 A CN202180066990 A CN 202180066990A CN 116235041 A CN116235041 A CN 116235041A
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CN
China
Prior art keywords
test strip
opening
carrier
housing
photodetector
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Pending
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CN202180066990.7A
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Chinese (zh)
Inventor
朱利亚诺·曼齐
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Ams Osram Co ltd
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Ams Osram Co ltd
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Publication of CN116235041A publication Critical patent/CN116235041A/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7756—Sensor type
    • G01N2021/7759—Dipstick; Test strip
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7796—Special mountings, packaging of indicators

Abstract

A test strip cartridge (1) includes a housing (85) defining a first opening (86) configured to receive a sample liquid, the housing further defining a second opening (87) configured to provide an optical path into the housing (85) and a spacing structure (91). It further comprises a carrier (19) comprising at least one photodetector (15), said at least one photodetector (15) being aligned with a second opening (87) of said housing (85). It further comprises a test strip (10), said test strip (10) comprising a sample pad (80) aligned with said first opening (86), and at least one active area (16) aligned with said second opening (87) and with said at least one photodetector (15). The housing (85) encloses the carrier (19) and the test strip (10) such that the test strip (10) is separated from the carrier (19) by the spacing structure (91) and arranged between the second opening (87) and the carrier (19).

Description

Test strip box, monitoring equipment and method for manufacturing test strip box
The present disclosure relates to a test strip cartridge, a monitoring device and a method of manufacturing a test strip cartridge.
Background
The test strip cartridge is part of the monitoring device. The portion can be inserted prior to testing or measurement and removed after testing or measurement. The monitoring device is typically portable and can therefore be used for point-of-care applications for medical diagnostics and environmental testing. The test strip cartridge can be used for lateral flow testing. The test strip box comprises test paper of porous material, and utilizes capillary action of the porous material and the capability of the porous material to bind to the labeled molecules.
A sample liquid (e.g., water, urine, blood, or other liquid) is provided to the test strip. The sample liquid flows and chemically reacts using the capillary effect of the porous material. Typically, the chemical reaction causes a color change at a predetermined active region of the porous material. The active region may have the form of a narrow line or a wide line. The reaction typically occurs at two active regions (lines respectively) of the porous material. Typically, the color change is monitored by visual inspection. Such tests have several advantages but still suffer from drawbacks such as sensitivity and multi-analyte detection as well as complex assembly processes. Finding a solution to these drawbacks may bring more testing to the home environment.
The following is a non-exhaustive list of prior art patent and non-patent documents regarding lateral flow test devices: US 2012/03251519 A1, EP 2905607 A1, US 9606115 B2, US 2008/0171397A1, US 5580794A, US 7220597 B2, US 9243997 B2, US 7317532B2, US 7315378 B2, US 7044919 B1, US 7141212 B2, US 2005/0250141A1, US 2006/0263907 A1, WO 2008/098722 A1, US 2005/0227371A1, US 2015/024355 A1, US 2006/0133786 A1, US 6485982B1, US 6663833 B1, US 6841959 B2, US 7090803 B2, US 7144742 B2, US 8399261B2, US 8865088B2, US 9638704B2, WO 2006/073500, US 4943522A, caputo et al "Smart thin layer chromatography plate", lab Chip,2007,7,978-980.
An object of the present invention is to provide a test strip cartridge, a monitoring apparatus, and a method of manufacturing a test strip cartridge capable of efficiently reading measurement results and efficiently assembling the test strip cartridge.
These objects are achieved by the subject matter of the independent claims. Further developments and embodiments are described in the dependent claims.
Disclosure of Invention
In an embodiment, the test strip cartridge includes a housing. The housing defines a first opening configured to receive the sample liquid and a second opening configured to provide an optical path into the housing. The housing also includes a spacing structure.
In addition, the test strip cartridge includes a carrier. The carrier includes at least one photodetector aligned with the second opening of the housing.
The test strip box also comprises a test strip. The test strip includes a sample pad aligned with the first opening and at least one active region aligned with the second opening and the at least one photodetector.
The housing encloses the carrier and the test strip such that the test strip is spaced apart from the carrier by a spacer structure and disposed between the second opening and the carrier.
Both the test strip with at least one active area and the carrier with at least one photodetector have a fixed position within the housing. The at least one photodetector, the at least one active region, and the second opening are aligned with one another. This may mean that the at least one active region is arranged between the photodetector and the second opening of the housing in a vertical direction extending perpendicular to the main extension plane of the carrier. The area of the at least one photodetector overlaps the area of the second opening and the area of the at least one active region in a lateral direction extending parallel to the main extension plane of the carrier. Thus, an optical path is provided such that optical energy is transmitted through the second opening and the active area of the test strip. At least one photodetector below the at least one active region is capable of detecting transmitted light.
At the location where at least one photodetector and at least one active region are present, a cavity may exist between the carrier and the test strip. In the transverse direction, the cavity is defined by the housing, in particular by the spacer structure. In the vertical direction, the cavity is defined by the carrier on the bottom side and the test strip on the top side. The cavity may be filled with air or gas.
The sample pad is aligned with the first opening of the housing. This can mean that in the vertical direction, the sample pad is arranged below the first opening. In the lateral direction, the area of the sample pad overlaps with the area of the first opening. Thus, the sample liquid can be inserted onto the sample pad of the test strip via the first opening.
Since both the carrier and the test strip are located inside the housing, the distance from the photodetector to the active area is short. The position of the at least one photodetector is predetermined relative to the at least one active region such that it is efficient and reproducible for detecting light transmitted or emitted by the at least one active region. However, the at least one photodetector is not directly attached to the test paper, for example by flip-chip bonding. Instead, the at least one photodetector is arranged on a separate carrier under the test paper. In this way, the manufacturing process is facilitated, as no complex flip chip technology is required. Thus, the manufacturing process achieved is very cost-effective. The test strip cartridge may be devoid of a light source. This means in particular that no light source may be arranged in the housing, for example on a carrier. The light source for transmission measurement may consist of an external reading device, as described below.
In an embodiment, the sample pad of the test strip is configured to absorb the sample liquid and direct the sample liquid forward to the at least one active region.
In an embodiment, the at least one active region may have the form of a line, square, rectangle, dot, circle or oval, respectively. The plurality of active regions may be arranged like a matrix, for example as a dot matrix or a square matrix. Such active areas may have different colors or may have the same color. The at least two active regions may have different colors. The at least two active regions may have the same color.
The second opening of the housing may also be referred to as a test opening. In embodiments, the housing may include more than one test opening. For example, the housing includes additional test openings that align with additional active areas of the test strip and/or with additional photodetectors on the carrier.
In an embodiment, the test strip comprises a porous material, in particular nitrocellulose, configured to transfer sample liquid from the sample pad to the at least one active region. The active region of the porous material is provided with a chemical substance (typically a compound) that reacts with the constituents of the sample liquid. The component may be an analyte contained in a sample liquid.
The porous material may comprise nitrocellulose. The porous material may be water absorbent. The porous material may be covered by a film. The film can protect the porous material. The film may be transparent or translucent. Transparency may also be referred to as optical transparency. The pore size, porosity and thickness of the porous material may be of a specific ratio, plus a specific chemical treatment. Advantageously, capillary action of the porous material can be used to transport the sample liquid.
The sample pad of the test strip may provide the sample liquid to the porous material directly or through the conjugate pad of the test strip. For example, the conjugate pad includes a chemical substance (typically a compound) that is designed to react with an analyte contained in a liquid.
In an embodiment, the test strip includes an absorbent pad for absorbing excess liquid from the porous material.
In an embodiment, the sample pad, the conjugate pad and the absorbent pad are also realized by a porous membrane or a porous layer, e.g. made of nitrocellulose.
In an embodiment, a porous material comprising a sample pad, a conjugate pad and an absorbent pad is arranged on a first side of the substrate. The substrate may be manufactured as a back card, for example as a plastic adhesive back card. The substrate may be optically transparent. By using this substrate, the rigidity of the test strip is enhanced. In addition, the test strip can be built in a stacked structure.
In an embodiment, the at least one photodetector is arranged on the side of the carrier facing the test strip. Thus, light transmitted by the active region of the test strip is directly incident on the photodetector.
The side of the carrier facing the test strip may be the major surface of the carrier. The at least one photodetector may be attached to the carrier by an adhesive layer such as glue or solder. By arranging the photodetector on the main surface of the carrier instead of directly on the test strip, the photodetector can be realized in the test strip cartridge without the need for complex flip chip technology.
In an embodiment, the test strip cartridge further comprises a third opening of the housing, electrical contacts of the carrier, which are arranged outside the housing beyond the third opening, and electrical wires on or in the carrier, which electrically connect the contact areas of the at least one photodetector to the electrical contacts beyond the third opening.
This can mean that the housing defines a third opening and that end of the carrier containing the electrical contacts can be brought outside the housing through the third opening. The electrical contacts may be arranged at a main surface of the carrier and/or at another surface of the carrier, for example at the back side of the carrier.
A carrier with conductive wires can provide power and signals to/from the photodetector. This can mean that the only electrical connection to the photodetector is through a conductive wire on or in the carrier. Since the electrical contacts are located outside the housing, the at least one photodetector can be electrically controlled by an external device (e.g., a monitoring device).
Since the test strip is located in the upper portion of the test strip cartridge, the first opening and the second opening are disposed at the upper side of the housing. The third opening is located on the underside of the housing because the carrier is disposed below the test strip. In an alternative embodiment, the third opening of the housing is located on the bottom side of the housing. Thus, contact with the conductive line is achieved from below.
Conductive lines can also be referred to as traces. The conductive lines may be made of copper, aluminum, or silver, among others. If the conductive lines are made of copper or aluminum, they may be etched. If the conductive lines comprise silver, silver ink may be used. On the carrier, the conductive lines may be partly designed as straight lines and partly as curved lines. The conductive lines may extend in parallel such that they are isolated from each other. The conductive wires are aligned with electrical contacts at the ends of the carrier outside the housing, at the contact areas of the photodetectors.
In an embodiment, the conductive lines include a power line, a reference potential line, and at least one bus line. The power supply line and the reference potential line can be utilized to provide power from a power source to the photodetector. Data can be transferred from the photodetector to other circuitry of the monitoring device via the at least one bus.
In an embodiment, the photodetector is implemented as a spectral sensor configured to detect light in at least two different wavelength regions, in particular in each case at least two different wavelength regions. Advantageously, two colors can be generated in one active area; each color can be measured individually by a spectral sensor. Thus, two components or two analytes can be detected in one active region. The spectral sensor may detect light in more than two, more than four, or more than eight different wavelength regions. These different wavelength regions may be in the visible light range or in the visible plus infrared range or in the visible plus near infrared range.
In an embodiment of the test strip cartridge, the inner surface of the housing comprises at least one of a step, a groove and/or a protrusion to receive the test strip and the carrier in a predetermined position to provide positional alignment between the second opening, the at least one active area and the at least one photodetector.
The inner surface does not face the environment of the housing, but faces the test strip and the carrier arranged inside the housing. For example, the inner surface of the housing is provided with a groove in which the carrier is arranged. This ensures that the carrier has a fixed position relative to the housing. The carrier is not movable or is only slightly movable in the lateral and vertical directions so that it can be aligned with the test strip.
The position of the test strip within the housing may be defined by steps and/or protrusions formed on the inner surface of the housing. Thus, the test strip has a fixed position relative to the housing. The test strip cannot move or can move only slightly in all directions so that it is aligned with the carrier.
In embodiments, the protrusion can also be configured to apply a force to the test strip or one or more ends of the test strip, respectively. In this way, the tension of the test strip can be achieved, which may also be beneficial in view of the alignment between the at least one active area and the at least one photodetector. This in turn improves the accuracy of evaluating the corresponding measurements performed by the test strip cartridge.
The steps, grooves and/or protrusions can also be referred to as alignment structures. In this sense, the spacer structure serves as an additional alignment structure, as it ensures that the carrier is separated from the test strip at a predefined distance.
In an embodiment, the distance between the at least one active area and the at least one photodetector is 0.3mm to 5mm. In another embodiment, the distance between the at least one active region and the at least one photodetector is 0.5mm to 3mm.
The distance between the at least one active area and the at least one photodetector is in a vertical direction. If there is more than one active area and more than one photodetector, the distance between each pair of respective active areas and the corresponding photodetector aligned with the respective active areas may have the dimensions described above. In this way, a short distance from the photodetector to the active region can be ensured. This in turn results in high efficiency and reproducibility of detecting light transmitted or emitted by the at least one active region.
In an embodiment, the test strip comprises at least two active regions. Thus, two components or two analytes of the sample liquid can be detected at the at least two active areas.
In an embodiment, the photodetector comprises at least two pixels, each pixel aligned with one of the at least two active regions. The pixels can be referred to as photodetector elements. The pixels may be implemented as photodiodes.
In an alternative embodiment, the first photodetector is aligned with one of the at least two active areas and the second photodetector is aligned with the other of the at least two active areas. The photodetectors may be arranged on the same carrier or even on the same chip (e.g. semiconductor chip).
According to another embodiment, the first opening and the second opening are provided at an upper side of the housing, wherein the test strip is arranged between the upper side and the carrier. In this embodiment, the first opening and the second opening are arranged on the same side of the housing.
According to an alternative embodiment, the first opening is arranged at an upper side of the housing and the second opening is arranged at an opposite lower side of the housing, wherein the test strip is arranged between the lower side and the carrier. Thus, the first opening and the second opening are arranged on different sides of the housing.
Terms such as "top," "bottom," "upper," "lower," "front," "rear," and the like do not necessarily refer to orientation in space, but are used in this disclosure to illustrate the distinguishability of various features relative to embodiments.
Different arrangements may be advantageous in terms of manufacturing the housing and assembling the individual components. Furthermore, the second opening providing the optical path may be located on a different side of the test strip cartridge depending on the position of the light source relative to the test strip cartridge. The second opening forms access to the potentially sensitive active area and the photodetector. By placing the second openings on the upper side or the lower side of the housing, respectively, these components can be better protected from environmental influences such as touch.
According to another embodiment, the at least one active area is arranged on a side of the test strip facing away from the carrier. This can mean that the active area faces the second opening of the housing such that the active area can be seen through the second opening. Advantageously, the test results can be determined by visual inspection in addition to evaluating the photodetector signals.
According to an alternative embodiment, the at least one active area is arranged on the side of the test strip facing the carrier. Thus, since the active region is closer to the photodetector and the color change of the active region is not distorted by the substrate of the test strip, the performance of transmission measurement is improved.
In these embodiments, the detection/measurement is not implemented as a measurement of reflected light, but rather a measurement of refraction/transmission/absorption. The light source may be placed on one side of the strip and the detection is accomplished by a photodetector on the other side of the strip. Thus, light is refracted, transmitted, or absorbed by the test strip. The test strip may be placed in a test strip cartridge such that at least one active area on one side of the test strip faces the photodetector and the test strip is illuminated from the opposite side thereof. Alternatively, the test strip may be placed in a test strip cassette such that at least one active area on one side of the test strip faces the light source and the opposite side of the test strip faces the photodetector.
According to a further embodiment, the test strip cartridge further comprises a light source arranged on the carrier. The light source is configured to emit light toward the at least one active region, and the at least one photodetector is configured to detect light reflected from the at least one active region.
The light source can be disposed adjacent to the photodetector such that it is aligned with the active area of the test strip. The light source and the photodetector can be substantially in the same plane. The light source can be separated from the photodetector by a light barrier such that light emitted by the light source does not directly reach the photodetector. Instead, the emitted light is reflected from the active region back to the photodetector. Thus, reflection measurements can be provided.
According to a further embodiment, the second opening defined by the housing tapers towards at least one active area of the test strip. This can mean that the diameter of the second opening becomes smaller towards the at least one active area. For example, the second opening forms a conical or parabolic shape. In other words, the side walls of the second opening are inclined with respect to the vertical direction. Light from a light source on the input side of the second opening (outside the cartridge) can be coupled into the second opening at a wide angle. In addition, the light can be reflected one or more times on the side wall of the second opening formed by the housing. Since the second opening tapers towards the active region (at the output side of the second opening), the light is effectively collimated such that the light intensity at the active region increases.
If the test strip comprises a plurality of active areas, each active area may be provided with a separate second opening. Thus, the test strip cartridge may comprise a plurality of second openings, wherein each second opening is assigned to an active area. As described above, each second opening may taper towards the assigned respective active region. Alternatively, at least part of the active regions share a common second opening.
The second opening can also be referred to as an aperture. In other words, the draft angle of the aperture is changed to collimate and focus the light onto the test strip. Thus, light collection efficiency and light collimation may be increased. Advantageously, refractive lenses are not required to improve light collection efficiency and light collimation. The housing may be a molding compound. Thus, a low cost and lens-free arrangement is provided to improve light collection efficiency and sensitivity. This also allows for a more relaxed tolerance in the distance between the active area and the photodetector.
In a further embodiment, a sidewall of the second opening defined by the housing is coated with a reflective layer. The reflective layer is arranged only on the sidewalls of the second opening, i.e. on the inner surface of the second opening. Thus, a reflective surface is provided on the side wall of the second opening. As an example, the reflective layer may be a lacquer. By means of the reflective layer, the light is reflected better on the side walls and the light collimation is increased.
Furthermore, a monitoring device is provided, comprising a test strip cartridge as described above. This means that all features disclosed for the test strip cartridge are also disclosed for and applicable to the monitoring device and vice versa.
In an embodiment, the monitoring device comprises a test strip cartridge, a light source, and a control circuit connected to the photodetector and the light source.
The test strip is positioned between the light source and a carrier comprising a photodetector. Thus, transmission measurement can be performed. Alternatively, the light source is arranged on a carrier within the test strip cartridge. Here, the light source can be considered as part of a test strip cartridge, and the test strip cartridge can perform reflectance measurements as described above. The monitoring device may be named a reader.
In an embodiment, the monitoring device is configured such that the test strip cartridge is selectively insertable into and removable from the monitoring device. Thus, the test strip cartridge is disposable, i.e. for a single test. The monitoring device is designed for multiple uses, for example, with different test strips for detecting different analytes or with test strips for detecting the same analytes.
Alternatively, the test strip cartridge can be used multiple times after the test strip is replaced. For example, the test strip cartridge can be designed such that it can be opened and closed. By doing so, the used test strip can be removed and an unused test strip can be inserted into the test strip cartridge. Advantageously, the housing and the carrier with the at least one photodetector are reusable.
Alternatively, the housing including the test strip is disposable. However, the carrier comprising at least one photodetector can be reused. For example, the test strip cartridge can be opened so that the carrier can be removed and inserted into a new housing that contains the unused test strip. In another embodiment, the carrier is capable of sliding out of the housing through the third opening. In the same way, it can be slid into a new housing containing unused test strips. From an environmental point of view, it is beneficial to reuse the housing and/or carrier.
In an embodiment, the control circuit is configured to detect whether a test strip cartridge is inserted and to provide an enable signal when the test strip cartridge is inserted. By generating the enabling signal, the monitoring device is able to detect whether the test strip cartridge is properly inserted into the monitoring device and/or is able to detect whether a proper test strip cartridge is inserted.
In an embodiment, the monitoring device is configured to perform a lateral flow test, abbreviated LFT or lateral flow immunochromatographic assay.
The objects herein are further solved by a method of manufacturing a test strip cartridge. All features disclosed for the test strip cartridge are also disclosed for and applicable to the method of manufacturing the test strip cartridge and vice versa.
In an embodiment, a method for manufacturing a test strip cartridge includes providing a carrier comprising at least one photodetector.
The carrier can be a Printed Circuit Board (PCB) on which the photodetector is mounted. For example, the photodetector can be attached to the carrier by an adhesive layer such as glue or solder. The carrier can include conductive wires for electrically connecting the photodetectors. To establish the electrical connection, the photodetector may be wire-bonded to the carrier. This means that wire bonds connect the conductive wires of the carrier to the contact areas of the photodetector.
The method further includes providing a test strip comprising a sample pad and at least one active region.
The test strip may further comprise a porous material, in particular nitrocellulose, which is operable to transfer sample liquid from the sample pad to the at least one active region. The active region of the porous material may be provided with a chemical substance (typically a compound) that reacts with a component of the sample liquid. The test strip may further include a conjugate pad and an absorbent pad such that a porous material including the sample pad, the conjugate pad, and the absorbent pad is disposed on the substrate. The substrate may be manufactured as a back card, for example as a plastic adhesive back card.
The method further includes providing a housing defining a first opening configured to receive the sample liquid and a second opening configured to provide an optical path into the housing, and a spacer structure. The housing may comprise a plastics material formed by a moulding technique such as injection moulding.
In addition, the method includes assembling the housing, the test strip, and the carrier such that the housing encloses the carrier and the test strip. In this process, the test strip is spaced from the carrier by a spacing structure and disposed between the second opening and the carrier. Further, the at least one photodetector, the at least one active region, and the second opening are aligned with one another, and the sample pad is aligned with the first opening of the housing.
Since both the carrier and the test strip are located inside the housing, the distance from the photodetector to the active area is short. This allows for high efficiency and reproducibility of detecting light transmitted or emitted by the at least one active region. The at least one photodetector is not directly connected to the test strip, but is arranged on a separate carrier. In this way, the manufacturing process is facilitated, as no complex flip chip technology is required. Thus, the manufacturing process achieved can be very cost-effective.
In a variant of the method, the method further comprises providing a third opening of the housing. The third opening can be located in a lower portion of the housing where the carrier is located. A portion of the carrier may extend through the third opening. The electrical contact is formed on the carrier outside the housing beyond the third opening. A conductive line is formed on or in the carrier, wherein the conductive line electrically connects the contact area of the at least one photodetector to the electrical contact beyond the third opening.
By doing so, an external device (e.g., a monitoring device) can electrically operate the test strip cartridge. In particular, at least one photodetector on the carrier can be energized and an electrical signal can be received through the electrical contacts and the conductive wires.
Other embodiments of the method will be apparent to the skilled reader from the embodiments of the test strip cartridge described above. For example, the method of manufacturing the test strip cartridge may be implemented by the test strip cartridge and the monitoring apparatus according to one of the above-described embodiments.
The test strip cartridge with embedded spectral sensor is configured for use in an optical assay reading device. The test strip cartridge is implemented as a smart test strip cartridge because it includes an embedded spectral sensor. The cartridge is configured for use in a lateral flow test system (abbreviated LFT system). LFT systems perform refraction and/or transmission and/or absorbance measurements.
The disclosure applies to the field of lateral flow testing at point of care (abbreviated PoC). The test strip in the test strip cartridge reacts with a substance present in the test liquid, for example by depositing a conjugated antibody on a nitrocellulose membrane, and the colour of the porous active region changes accordingly when the analyte binds to the conjugated antibody. The liquid to be tested may be referred to as a sample, sample liquid or analyte. Alternatively, the substance to be detected is referred to as an analyte. The substance to be detected may be a chemical element or compound.
An example of an application is a home pregnancy test. For example, the test is capable of detecting Human Chorionic Gonadotrophin (HCG) in the urine of a pregnant woman. This test utilizes the capillary action of porous paper and the ability to bind the labeled protein to cellulose. A two-line mode is typically used. The first line generates a yes/no signal (whether pregnant or not). The second line indicates whether the test was successful. Point of care testing (PoC testing) enables testing of patients when care is needed. This allows for faster diagnosis and thus faster treatment.
Other important applications are tests for identifying diseases. Particularly in the case of global pandemic outbreaks such as Covid19, it is important to provide a test that can quickly determine if a subject is infected. Furthermore, anyone can perform such tests at home, saving resources in public laboratories. The test strip cartridge can be manufactured inexpensively and efficiently, thereby ensuring quick and global distribution.
Typically, LFTs are read (analyzed) by the human eye and therefore lack the ability to accurately measure concentration changes. Lateral flow testing (also known as lateral flow immunochromatographic analysis) is an effective device intended to detect the presence (or absence) of a target analyte in a sample (matrix) without the need for specialized and expensive equipment, although there are many laboratory-based applications supported by reading devices. Typically, these tests are used for home testing or point-of-care testing or medical diagnosis for laboratory use.
The test strip cartridges described in the present disclosure aim to improve system performance, for example, by improving the position of the spectroscopic sensor relative to the membrane area to be analyzed (active area), further improving the accuracy of the reading and achieving better quantitative analysis. Furthermore, LFT PoC reading devices can be improved (e.g. by reducing the cost on the reader side).
Further, the present disclosure aims to simplify the manufacturing process and the final implementation: the spectral sensor is not placed directly on the test strip (e.g., by flip chip bonding the sensor to the back of the test strip) but on a separate carrier under the test strip cartridge. Thus, no complex and expensive flip-chip assembly is required.
Drawings
The following figures illustrate further aspects of the test strip cartridge, monitoring apparatus, and method of manufacturing the test strip cartridge. Parts and components of the test strip cartridge that are functionally identical or functionally identical are designated by identical reference numerals. The same or substantially the same components and parts may be described only in the drawings in which they first appear, and their description will not be repeated in subsequent drawings.
FIGS. 1A and 1B show examples of test strip cartridges;
FIGS. 2A and 2B show examples of test strip details;
FIGS. 3A and 3B show examples of photodetector details;
FIG. 4 shows an example of a test strip cartridge and monitoring device;
FIGS. 5 and 6 illustrate example arrangements according to embodiments;
FIG. 7 shows an arrangement according to an embodiment;
FIG. 8 shows an arrangement according to another embodiment;
FIG. 9 shows an arrangement according to another embodiment;
FIG. 10 shows an example of a test strip cartridge;
fig. 11 shows an example of a test strip cartridge and a monitoring device.
Detailed Description
Fig. 1A shows an example of a cross-sectional view of the test strip cartridge 1. The test strip cartridge 1 includes a housing 85, a test strip 10, and a carrier 19. The housing 85 may be manufactured as a plastic bracket. The housing 85 defines a first opening 86 configured to receive a sample liquid. This means that sample fluid can be inserted onto the test strip 10 through the first opening 86 of the housing 85. The first opening 86 of the housing 85 may also be referred to as a sample port.
The housing 85 also defines a second opening 87, the second opening 87 for providing an optical path into the housing 85. The second opening 87 of the housing 85 may also be referred to as a test opening. Light energy emitted by a light source (not shown) is transmitted into the housing via the second opening 87, with the test strip 10, carrier 19 in the housing. The housing 85 may include more than one test opening. In an alternative embodiment, not shown, the housing 85 defines an additional test opening. Light energy emitted by the light source is transmitted through the second opening 87 and the additional test opening to enter the housing 85. Thus, the second opening 87 and optional additional test openings provide an optical path into the housing.
The housing 85 also includes a spacing structure 91. The spacer structure 91 may be formed by a portion of the housing 85 on the inside thereof. A spacer structure 91 may be used to separate the test strip 10 from the carrier 19. This means that the spacer structure 91 is arranged between the test strip 10 and the carrier 19.
The carrier 19 comprises at least one photodetector 15. This can mean that the at least one photodetector 15 is arranged on or above a main surface 28 of the carrier 19. The at least one photodetector 15 is aligned with the second opening 87 of the housing 85. This can mean that the at least one photodetector 15 is arranged below the second opening 87 of the housing 85 in a vertical direction z extending perpendicular to the main extension plane of the carrier 19. In the transverse directions x, y extending parallel to the main extension plane of the carrier 19, the area of the at least one photodetector 15 overlaps the area of the second opening 87.
In the example according to fig. 1A, the carrier 19 comprises three photodetectors 15, 62, 63, each of which is aligned with a second opening 87 of the housing 85. Optionally, additional photodetectors 62, 63 may be aligned with respective additional test openings.
The test strip 10 includes a sample pad 80 aligned with a first opening 86 of a housing 85. This can mean that in the vertical direction z, the sample pad 80 is arranged below the first opening 86 of the housing 85. In the lateral directions x, y, the area of the sample pad overlaps with the area of the first opening 86. Thus, the sample liquid can be inserted onto the sample pad 80 of the test strip 10 via the first opening 86 of the housing 85.
The test strip 10 further includes an active region 16 aligned with the second opening 87 and the at least one photodetector 15. This can mean that in the vertical direction z the at least one active region 16 is arranged between the second opening 87 of the housing 85 and the at least one photodetector 15. In the lateral directions x, y, the area of the at least one active area 16 overlaps with the area of the second opening 87 and the at least one photodetector 15. Accordingly, light energy emitted by the light source is transmitted through the second opening 87 and the active region 16 of the test strip 10. At least one photodetector 15 located below the at least one active region 16 is capable of detecting transmitted light. Thus, the at least one photodetector 15 is arranged on the side of the carrier 19 facing the test strip 10. This side may be the main surface 28 of the carrier 19.
In the example shown in fig. 1A, the test strip 10 includes two additional active regions 60, 61, the active regions 60, 61 being located horizontally beside the active region 15. The number of active areas 15, 60, 61 may be matched to the number of photodetectors 15, 62, 63. Alternatively, the number of active areas 15, 60, 61 may be matched to the number of pixels of the at least one photodetector 15. In this way, each of the photodetectors 15, 62, 63 or pixels may be aligned with one of the active areas 16, 60, 61, respectively, as shown in fig. 1A. The second opening 87 of the housing 85 has a form such that light emitted by the light source reaches the plurality of active areas 16, 60, 61.
In the example of fig. 1A, the photodetector 15 is disposed below the active region 16 and aligned with the active region 16 such that the photodetector 15 receives light from the active region 16. Accordingly, an additional photodetector 62 is disposed below the additional active region 60 and aligned with the additional active region 60. The second additional photodetector 63 is arranged below the second additional active region 61 and aligned with the second additional active region 61. Thus, each photodetector 15, 62, 63 is disposed beneath and aligned with one of the active regions 16, 60, 61. The additional photodetector 62 and the second additional photodetector 63 may be implemented as spectral sensors.
Each photodetector 15, 62, 63 may include a photodetector array 31 (shown in fig. 3A and 3B). Thus, each photodetector 15, 62, 63 may be configured to detect light of a different spectral range emitted by the active region 16, 60, 61. The photodetectors 15, 62, 63 may be implemented using separate integrated circuits or chips. Multiple spectral sensors can be used to fabricate the carrier.
The detection/measurement is not implemented as a reflected-ray measurement, but as a refraction/transmission/absorption measurement. The light source will be placed on one side of the test strip 10 and detection is accomplished by the photodetectors 15, 62, 63 on the other side of the test strip 10. Thus, light is refracted, transmitted, or absorbed by the test strip 10.
The housing 85, the test strip 10 and the carrier 19 are arranged such that the housing 85 encloses the carrier 19 and the test strip 10. The test strip 10 is spaced from the carrier 19 by a spacing structure 91 and is disposed between the second opening 87 and the carrier 19.
A cavity 88 is formed between the carrier 19 and the test strip 10 at the location where the photodetector 15, 62, 63 is present. In the transverse directions x, y, the cavity 88 is defined by the housing 85, in particular by the spacer structure 91. In the vertical direction z, the cavity 88 is defined by the bottom side of the carrier 19 and the upper side of the test strip 10. The cavity 88 can be filled with air or gas.
The distance between the test strip 10 and the carrier 19 is defined by the vertical extent of the spacer structure 91. Thus, the distance D between the at least one active region 16 and the at least one photodetector 15 is defined by the vertical extent of the spacer structure 91. For example, the distance D between the at least one active region 16 and the at least one photodetector 15 is 0.5mm to 15mm. Optionally, the distance D between the at least one active area 16 and the at least one photodetector 15 is 1mm to 10mm.
The carrier 19 may include conductive lines 20-27 (as shown in fig. 3A), the conductive lines 20-27 being capable of electrically contacting the contact areas 40-47 (as shown in fig. 3A) of the at least one photodetector 15. Moreover, the conductive wires 20 to 27 may be in electrical contact with the electrical contacts 89 of the carrier 19. In particular, the carrier 19 may comprise a power supply line 20, a reference potential line 21 and at least one bus 22. The carrier 19 may also comprise a further bus 23.
For example, the electrical contact 89 may be arranged at one end of the carrier 19. Thus, the housing 85 may include a third opening 90 such that a portion of the carrier 19 is located outside of the housing 85. The electrical contacts of the carrier 89 may be disposed outside the housing 85, outside the third opening 90. The electrically conductive wires 20 to 27 may be arranged on or in the carrier 19 and electrically connect the contact areas 40 to 47 of the at least one photodetector 15 to the electrical contacts 89 outside the third opening 90.
In an alternative embodiment, not shown, the opening 90 of the housing 85 is located on the bottom side of the housing 85. Thus, contact with the conductive lines 20 to 27 is achieved from below. The first opening 86 and the second opening 87 are located at the upper side of the housing 85, and the third opening 90 is located at the lower side of the housing 85.
Fig. 1B shows an example of the test strip cartridge 1 in a perspective cut-away view through the test strip cartridge 1. In this example, the test strip 10 includes two active regions 16, 60 that are aligned with two corresponding photodetectors 15, 62 on the carrier 19.
A number of electrically conductive wires 20 to 22 are arranged in or on the carrier 19. For example, the first conductive line 20 may include a power line. The second conductive line 21 may comprise a reference potential line and at least the third conductive line 22 may comprise a bus line. The electrically conductive wires 20 to 22 electrically connect the contact areas (not shown) of the photodetectors 15, 62 to electrical contacts 89 on the carrier 19, the electrical contacts 89 being arranged outside the housing 85.
As can be seen in fig. 1B, the housing 85 of the test strip cartridge 1 includes an inner surface that includes a number of grooves 92, steps 93, and protrusions 94. These grooves 92, steps 93 and protrusions 94 are arranged to receive the test strip 10 and the carrier 19 at predetermined positions and to provide positional alignment between the second opening 87, the active areas 16, 60 and the photodetectors 15, 62.
For example, the inner surface of the housing 85 provides a groove 92, and the carrier 19 is disposed in the groove 92. This ensures that the carrier 19 has a fixed position relative to the housing 85. The carrier is not movable or is only slightly movable in the lateral directions x, y and the vertical direction z so as to be alignable with the test strip 10.
The position of the test strip 10 within the housing 85 is defined by a protrusion 94 and a step 93 formed on the inner surface of the housing 85. Thus, the test strip 10 has a fixed position relative to the housing 85. In each of the x, y, z directions, the test strip 10 cannot move or can move only slightly so that the test strip 10 is aligned with the carrier 19. The tab 94 may also be configured to apply a force to one or more ends of the test strip 10. In this way, tension of the test strip 10 can be achieved, which may also be beneficial in terms of alignment between the active areas 16, 60 and the photodetectors 15, 62. This in turn improves the accuracy of evaluating the corresponding measurements.
Fig. 2A shows an example of the test strip 10 in a cross-sectional view. The test strip 10 is provided with a plurality of active areas 16, 60, 61. In addition, the strip comprises a porous material 14 (in particular nitrocellulose), the active region 16, 60, 61 being embedded in the porous material 14. The porous material 14 may transfer sample liquid from the sample pad 80 to the active regions 16, 60, 61. The active areas 16, 60, 61 are provided with chemicals which react with the constituents of the sample liquid.
The porous material 14 is translucent or transparent. The porous material 14 has the form of a layer, film or sheet. The porous material 14 may be made of nitrocellulose. The porous material 14 may be manufactured as a nitrocellulose membrane. The porous material 14 is configured such that liquid can flow laterally within the porous material 14. The direction of flow F is indicated by the arrow. The flow F of the liquid is performed by capillary effect of the porous material 14. This liquid may be named sample liquid.
The number of active areas 16, 60, 61 may be greater than 1, greater than 2, or greater than 3. The active regions 16, 60, 61 may be rectangular, square, circular or oval. The active regions 16, 60, 61 may, for example, reach from one boundary of the porous material 14 to another boundary of the porous material 14. In the cross section shown in fig. 2A, the flow F of the sample liquid in the porous material 14 is from right to left.
The test strip 10 includes a sample pad 80, a conjugate pad 81, and an absorbent pad 82. The sample pad 80, the bonding pad 81 and the absorbent pad 82 are arranged on the main side 12 of the substrate 11 and surround the side surfaces of the porous material 14. Pads 80 through 82 will be further explained in connection with fig. 2B.
Fig. 2A also shows a light source 70. The light source 70 emits light as indicated by the arrow. The light source 70 may be implemented as a spectral source. Light is emitted by the light source 70 at a wide angle and reaches the active region 16. The light of the light source 70 also reaches the additional active region 60 and the further active region 61. Thus, light emitted by the light source 70 reaches each of the active regions 16, 60, 61. The light source 70 may be made as a broadband spectrum source or a blackbody spectrum source (BB spectrum source for short). The light source 70 may emit light, for example, in the range of 350nm to 1050nm or 350nm to 750 nm. Alternatively, the light source 70 may be implemented as a narrow-band light source (having, for example, a very limited bandwidth, such as a specific light color source or a pure near infrared light source).
The substrate 11 may be translucent or transparent. In addition, the porous material 14 may be translucent or transparent. Thus, light from the active region 16, as indicated by the arrow, can reach at least one photodetector 15 (not shown in this figure) below the active region 16. The optical properties of the active region 16 depend on the optical properties of the porous material 14, the chemicals immobilized on the porous material 14 in the active region 16, and the concentration of the analyte in the sample fluid. For example, the light source 70 emits light of a broad spectrum. The active region 16 transmits light, for example red light, only in a small spectral range. The amount of light emitted or transmitted by the active region 16 depends on the concentration of the analyte in the sample fluid. The value of the light may rise as the analyte concentration increases. Light transmitted by the active region 16 is detected by a photodetector 15.
The additional photodetector 62 (not shown) and the second additional photodetector 63 (not shown) are capable of detecting light from the additional active region 60 and the second additional active region 61. The different active areas 16, 60, 61 may have different substances to react with the liquid analyte. Accordingly, the optical characteristics of the respective active regions 16, 60, 61 may be different and detected by the photodetectors 15, 62, 63 (not shown).
In an alternative embodiment, not shown, the light source 70 emits light at one wavelength and the light is absorbed by the substance in the active region 16, wherein the substance in the active region 16 emits light at another wavelength. Thus, the active region 16 emits light using fluorescence or phosphorescence. In this case, the light source 70 emits light of a small wavelength band. The amount of light emitted by the active region 16 depends on the amount of analyte that reacts with the substance immobilized at the active region 16. For example, the light source 70 is implemented as a laser, a light emitting diode, or a vertical cavity surface emitting laser (abbreviated as VCSEL).
In an alternative embodiment, not shown, the light source 70 is omitted. Thus, the monitoring device has no light source. The reaction of the chemical species of the active region 16 with the analyte in the liquid results in the emission of light. Thus, the active region 16 emits light using chemiluminescence.
Fig. 2B shows an example of a perspective view of the test strip 10. The porous material 14 includes an active region 16 and an additional active region 60. The active region 16 may be implemented as a test active region, for example as a test line. The additional active region 60 may be implemented as a control active region, for example as a control line. Thus, a change in the optical properties at the additional active region 60 indicates that the test is performed correctly, e.g., that a sufficient amount of liquid has been provided to the test strip 10. The test results are detected by measuring the optical properties at the active region 16. The substrate 11 may be manufactured as a back card, for example as a plastic adhesive back card.
In addition, the test strip 10 includes a sample pad 80. Sample pad 80 is configured to receive a sample liquid, such as a sample liquid from a user or liquid dispenser. The sample pad 80 is located on the main side 12 of the substrate 11. In addition, the test strip 10 includes a conjugate pad 81. The conjugate pad 81 is used to provide a substance to the sample fluid. The bond pads 81 are located on the major side 12 of the substrate 11. A conjugate pad 81 is disposed between the sample pad 80 and the porous material 14. The sample pad 80 is overlapped on the bonding pad 81. Thus, with this overlap an efficient transfer of liquid from the sample pad 80 to the conjugate pad 81 can be achieved. The bonding pad 81 is superposed on the porous material 14. By means of the overlap region, liquid is effectively transferred from the bonding pad 81 to the porous layer 14. Sample pad 80 and conjugate pad 81 are located at a first end of the test strip.
The test strip 10 includes an absorbent pad 82 on the major side 12 of the substrate 11. An absorbent pad 82 is disposed at the second end of the test strip 10. The absorbent pad 82 is in contact with the porous material 14. The absorbent pad 82 overlaps the porous material 14. Thus, the transfer of liquid from the porous material 14 to the absorbent pad 82 is accomplished by this overlap. As indicated by arrow F, liquid flows from the sample pad 80 to the absorbent pad 82 via the conjugate pad 81 and the porous material 14. The sample liquid inserted onto the sample pad 80 only partially reaches the absorbent pad 82. Photodetectors 15, 62 (not shown) detect changes in optical characteristics at active areas 16, 60.
Typically, the test strip 10 is built up in a stacked configuration as follows: the test strip 10 includes a substrate 11. The material of the base material 11 is made of, for example, polystyrene, vinyl or polyester. Typically, the substrate 11 is clear (i.e. meaning transparent) or may be opaque. The opaque substrate 11 may include a transparent or translucent window at the active area 16. The window may be realized by inserting a transparent or translucent material or by reducing the thickness of the substrate 11. The substrate 11 is used to carry a porous material 14, which porous material 14 may also be referred to as a membrane 14. Then, on one side or end of the membrane 14, a conjugate pad 81 is placed on the membrane 14, followed by a sample pad 80. On the other side or end of the membrane 14, an absorbent pad 82 is placed. Two lines, control and test lines 16, 60, respectively, show the validity of the test and the test results.
Fig. 3A shows an example of the photodetector 15 arranged on the carrier 19 in the test strip cartridge 1 shown in fig. 1A and 1B. In fig. 3A, a perspective view of the photodetector 15 is shown. The photodetector 15 includes at least one pixel 30 located on a first side 17 of the photodetector 15. The pixel 30 may be referred to as a photodetector element. The photodetector 15 may include an array 31 of pixels 30 located on the first side 17 of the photodetector 15. The photodetector array 31 may be an n×m pixel array. In the example shown in fig. 3A, the photodetector array 31 is a 4×4 array. The pixels 30 of the photodetector array 31 may be sensitive to light of different areas. The pixel 30 may be implemented as a photodiode. Thus, the photodetector array 31 implements a spectral sensor. Furthermore, the photodetector 15 may comprise an additional pixel 32 and a further pixel 33, which are larger than the pixel 30 of the photodetector array 31 and are located in the vicinity of the photodetector array 31.
Furthermore, the photodetector 15 comprises contact areas 40 to 47 on the first side 17 of the photodetector 15. The contact areas 40 to 47 are arranged at the boundary of the photodetector 15 or at both boundaries. There is a distance between the contact areas 40 to 47 and the photodetector array 31. The contact areas 40 to 47 can be realized as bond pads or chip bumps.
A second face 18 of the photodetector 15, opposite the first face 17, is attached to a major surface 28 of the carrier 19. The carrier 19 may be implemented as a Printed Circuit Board (PCB). The photodetector 15 can be attached to the carrier 19 by adhesive or by soldering. The photodetector 15 comprises a plurality of bond wires 58 for electrically connecting the photodetector 15 with corresponding connection points 50 to 57 provided on the carrier 19 adjacent to the photodetector 15. Conductive wires 20 to 27 arranged on or in carrier 19 reach connection points 50 to 57 such that they are electrically connected with photodetector 15. The electrically conductive wires 20 to 27 are electrically connected to electrical contacts 89 (not shown in fig. 3a, but shown in fig. 1A and 1B) at one side of the carrier 19.
The conductive lines 20 to 27 may also be referred to as "traces". The conductive lines 20 to 27 are made of copper, aluminum, or silver (e.g., made of printed silver ink) or other metals. The conductive lines 20 to 27 made of copper or aluminum may be corroded. The conductive lines 20 to 27 may be partially designed as straight lines and partially designed as curved lines. The conductive lines 20 to 27 may extend in parallel. The conductive lines 20 to 27 are aligned with the contact areas 40 to 47 of the photodetector 15 and with the electrical contacts 89 at the end of the carrier 19. The conductive lines 20 to 27 may be rectangular, for example. For example, the first conductive line 20 may be implemented as a power line. The second conductive line 21 may be implemented as a reference potential line. The third line 22 may be designed as a bus. The fourth line 23 may be designed as another bus. Other conductive lines 24 to 27 may also be implemented as buses. Thus, the conductive lines 20 to 27 comprise at least one bus line 22 to 27. Buses 22 to 27 may be implemented as inter-integrated circuit buses, I for short 2 And C line. Thus, an electrical signal from the photodetector 15 can be received.
The number of conductive lines 20 to 27, contact areas 40 to 47 and connection points 50 to 57 as shown in fig. 3A is by way of example only. It is also possible that fewer conductive lines 20 to 27, contact areas 40 to 47 and/or connection points 50 to 57, respectively, are present on the carrier 19 and the photodetector 15. In particular, the carrier 19 may comprise only a power supply line 20, a reference potential line 21 and two buses 22, 23 electrically connecting the photodetector 15 to respective contact areas 89 of the carrier 19.
In an alternative embodiment, not shown, the second face 18 of the photodetector 15 is arranged on the main surface 28 of the carrier 19 by means of an adhesive layer. Conductive vias may be used to electrically connect the first face 17 of the photodetector 15 with the second face 18 of the photodetector 15. The conductive vias may be implemented as Through Substrate Vias (TSVs). Solder bumps are provided at the second side 18 of the photodetector 15 to electrically connect the photodetector 15 with the connection points 50 to 57 on the carrier 19. In this case, wire bonding is not required.
In an alternative embodiment, not shown, the photodetector 15 and the additional photodetectors 62, 63 are implemented on one chip. The photodetectors 15, 62, 63 may be implemented as pixels 30 or as a photodetector array 31 on one die or chip. The photodetector 15 may be fabricated as a spectrum sensor integrated circuit.
Fig. 3B shows another example of the photodetector 15, which is a further improvement of the photodetector 15 shown in fig. 3A. The photodetector array 31 is located at or near the center of the photodetector 15. The first contact area 40 is realized as a supply contact area for receiving a supply voltage VCC. The second contact region 41 is realized as a reference potential contact region for receiving a reference potential GND. At least one contact region 42 is designed as a bus contact region. For example, the third contact region 42 and the fourth contact region 43 are realized as bus contact regions, for example for an inter-integrated circuit bus (abbreviated as I 2 C bus). For example, the third contact region 42 and the fourth contact region 43 receive signals or provide I 2 A C bus signal, such as a data signal SDA and a clock signal SCL. The fifth contact area 44 may be designed for a bus or for other purposes as well as to receive the INT signal.
Fig. 4 shows an example of a monitoring device 100 comprising a light source 70. The test strip cartridge 1 as described above can be inserted into the monitoring apparatus 100 and can be taken out again. The monitoring device 100 may be referred to as a card reader or PoC card reader. The monitoring device 100 includes a device housing 101. The light source 70 and a portion of the test strip cartridge 1 are located in the device housing 101. In fig. 4, the monitoring device 100 is merely illustrative and exemplary.
The monitoring device 100 may include a receptacle 103 having pins or spring contacts 108. Pins or spring contacts 108 of receptacle 103 contact electrical contacts 89 of carrier 19 outside of housing 85. The monitoring device 100 may comprise a guiding member (not shown) to guide the test strip cartridge 1, for example into the receptacle 103. The device housing 101 may include a component that provides light shielding that shields light from outside the monitoring device 100 from penetrating into the interior of the device housing 101.
Furthermore, the monitoring device 100 comprises a control circuit 102, the control circuit 102 being connected to the light source 70 and to the at least one photodetector 15 via the socket 103, the electrical contacts 89 and the electrically conductive wires 20 to 27. The control circuit 102 is configured to detect whether the test strip cartridge 1 is inserted and to provide an enable signal when the test strip cartridge 1 is inserted. Further, the monitoring device 100 may comprise an interface 104 connected to the control circuit 102 for providing information obtained by the monitoring device 100 to an external device. The monitoring device 100 may also include a display 105 for displaying information obtained by the control circuit 102. For example, the display 105 may display an enable signal to indicate that a user may apply a sample liquid to the test strip 10. Further, the display 105 displays the test results. The monitoring device 100 may include a power source 106, such as a battery. Furthermore, the monitoring device 100 may comprise a user interface 107, for example a button for starting a measurement process.
The monitoring device 100 does not have a complex mechanical switch for detecting whether the test strip cartridge is inserted into the monitoring device 100. The test strip cartridge 1 will have electrical connections (terminations) corresponding to the various signal and power lines on the carrier 19. The electronics on the monitoring device 100 will be able to detect I 2 The spectrum sensor 15 on line C detects the insertion of the test strip cartridge 1 and thus enables the monitoring device 100 in a manner ready for running measurements.
Alternatively, at I 2 A protection system can be implemented on the C-line to avoid insertion of counterfeit test strip cartridges. The test strip cartridge 1 may be shielded in a manner allowing only electronic reading. This can lead toOver-complete coverage of the area or sides where the photodetectors 15, 62, 63 are located is accomplished leaving only small slits to allow the incoming light to reach the at least one active area 15.
The test strip cartridge 1 may be configured to perform reactance measurement. To achieve a correct measurement, the test strip cartridge 1 may be provided with a qualified spectrometer photodetector integrated circuit.
A further arrangement is shown in cross-section in fig. 5. For ease of illustration, certain components of the test strip cartridge 1 or the monitoring device 100, respectively, are omitted. In the example of fig. 5, the light source 70 is arranged on the carrier 19 adjacent to the photodetector 15. The light source 70 can be arranged near the photodetector 15, which means that the distance between these components can be less than 10mm, less than 5mm or even less than 2mm. The light source 70 may be mounted on the carrier 19 by soldering and/or by adhesive. Wires (not shown) for the light source 70 can also be arranged on the carrier 19 and can be electrically connected to the electrical contacts 89. The light source 70 and the photodetector 15 are both aligned with the active region 16 of the test strip 10. In the example shown, the active region 16 is arranged on the side of the test strip 10 facing the carrier 19.
Fig. 6 shows a perspective view of the exemplary arrangement according to fig. 5. Furthermore, it shows a light barrier 110 separating the light source 70 from the photodetector 15. Light from light source 70 impinges on active region 16 on test strip 10. Light reflected or emitted by the active region 16 is detected by the photodetector 15. The light source 70 and the photodetector 15 are substantially in the same plane; the active region 16 is located above this plane. The light barrier 110 protects the photodetector 15 from light directly generated by the light source 70. The light source 70 may be a light emitting diode, for example, emitting white light or broadband white light. An example of an optical path is also shown in fig. 6.
Fig. 7 shows the test strip cartridge 1 according to fig. 1A. Further, a further carrier 71 is shown, on which further carrier 71 a plurality of light sources 70 are arranged. For example, as shown in fig. 7, the number of light sources can be matched to the number of active areas 16, 60, 61 and/or to the number of photodetectors 15, 62, 63. Another carrier 71 comprising a light source 70 may be part of the monitoring device 100 or another external device. The light source 70 is aligned with the second opening 87. It can be seen that in the example shown, the first opening 86 and the second opening 87 are arranged on the same side of the housing 85, i.e. the upper side 95. In the vertical direction z, the test strip 10 is arranged between the upper side 95 of the housing 85 and the carrier 19. Furthermore, it can be seen that the active areas 16, 60, 61 are arranged on the side of the test strip 10 facing away from the carrier 19.
Fig. 8 shows another arrangement in which the first opening 86 and the second opening 87 are arranged on different sides of the housing 85. The first opening 86 is arranged on an upper side 95 of the housing 85, and the second opening 87 is arranged on a lower side 96 of the housing 85 (the housing 85 is shown upside down). In this example, the test strip 10 is disposed between the underside 96 of the housing 85 and the carrier 19. Furthermore, it can be seen that the active areas 16, 60, 61 are arranged on the side of the test strip 10 facing the carrier 19. Again, the test strip cartridge 1 is shown in its positional relationship with another carrier 71 comprising a light source 70, which light source 70 may be part of the monitoring device 100 (not shown).
Another possible arrangement is shown in cross section in fig. 9. For ease of illustration, certain components of the test strip cartridge 1 or the monitoring device 100, respectively, are omitted. In the example of fig. 9, the light source 70 is arranged on another carrier 71 outside the test strip cartridge 1. Therefore, the test strip cartridge 1 does not include the light source 70. Fig. 9 shows the second opening 87 defined by the housing 85 in more detail. It should be noted that the test strip cartridge 1 may include more than one second opening 87. However, for ease of illustration, only one second opening 87 assigned to one active region 16 is shown. The second opening 87 tapers toward the active region 16 on the test strip 10. This means that the diameter of the second opening is larger on the input side (where the light source 70 is located) and smaller on the output side (where the active region 16 is located). As shown, the second opening 87 may be conical in shape. This means that the second opening may have the shape of a truncated cone or a frustum. In other words, the side wall of the second opening 87 may define a surface housing of a truncated cone. However, different shapes (e.g., parabolic shapes) are also possible. Light from light source 70 can be coupled into the second opening at a wide angle. Light rays (represented by arrows) are reflected at the sidewalls of the second opening 87. Since the second opening 87 tapers towards the active region 16, the light is effectively collimated such that the light intensity at the active region 16 increases. This effect can be enhanced if the side walls are coated with a reflective layer 97, as shown in fig. 9. Light is directed from one side of the test strip 10 to the active region 16. On the other side of the test strip 10 is provided a carrier 19 comprising a photodetector 15. The photodetector 15 detects a color change of the active region 16. Due to the advantageous design of the second openings 87, the light intensity at the active surface 16 is increased. Therefore, the requirement for the distance D between the photodetector 15 and the active region 16 can be relaxed.
In fig. 10 a perspective view of an exemplary embodiment of the test strip cartridge 1 is shown. Also, certain components of the test strip cartridge 1 are omitted for ease of illustration. The test strip cartridge 1 according to fig. 10 shows a handle bar 98 at one end of the test strip cartridge 1 at one side of the first opening 86. The handle bar 98 can have a corrugated surface to ensure a safe handling by the user with a grip. The first opening 86 may be funnel-shaped to receive the liquid under test. In addition, the housing 85 includes a collar (collar) 99, which collar 99 may act as a mechanical barrier when the test strip cartridge 1 is inserted into the monitoring device 100 (not shown). Collar 99 is implemented as a protruding structure of housing 85 such that it protrudes from the rest of housing 85 in the lateral direction x, y and/or the vertical direction z. The test strip 10 within the housing 85 may include three active areas 16, 60, 61, as shown. Each active region 16, 60, 61 is provided with a separate second opening 87 such that there is a one-to-one correspondence between the active regions 16, 60, 61 and the second openings 87. In other words, each active region 16, 60, 61 is assigned to one second opening 87. The second opening 87 may be realized according to fig. 9. A plurality of grooves 92, steps 93 and/or protrusions 94 (not explicitly labeled) are provided inside the housing 85 to accommodate the test strip 10. Thus, the sample pad 80 and the active regions 16, 60, 61 may be aligned with the respective openings 86, 87 of the housing 85. The housing 85 also provides space for the carrier 19 and the photodetectors 15 (e.g., three photodetectors 15, 62, 63 corresponding to the three active areas 16, 60, 61). The power supply for the at least one photodetector 15 may also be disposed within the housing 85. However, the power supply may also be arranged in the monitoring device (e.g. power supply 106 in fig. 4). The housing 85 may be composed of several assembled components. For example, the housing 85 or components of the housing 85 are made of injection molded material (e.g., plastic).
Fig. 11 shows the test strip cartridge 1 according to fig. 10 inserted into the monitoring device 100. For the monitoring device 100, only the device housing 101 and the light source 70 inside the device housing 101 are shown. The test strip cartridge 1 can be inserted into and removed from the monitoring device 100 as shown. The device housing 101 may include a receiving structure 109 to receive the collar 99 of the test strip cartridge 1. Thus, the test strip cartridge 1 can be accurately aligned with the monitoring device 100 such that the light source 70 is aligned with the second opening 87. The device housing 101 may be made up of several parts that are assembled. For example, the device housing 101 or parts of the device housing 101 are made of injection molded material (e.g., plastic).
Embodiments of the test strip cartridge 1, the monitoring device 100 and the method of manufacturing the test strip cartridge 1 disclosed herein have been discussed with the aim of familiarizing the reader with innovative aspects of the concept. While the preferred embodiments have been shown and described, many changes, modifications, equivalents and substitutions of the disclosed concepts may be made by those skilled in the art without departing from the scope of the claims.
It is to be understood that the present disclosure is not limited to the embodiments disclosed and the details specifically shown and described above. Rather, the features recited in the individual dependent claims or in the description may be advantageously combined. Furthermore, the scope of the present disclosure includes those variations and modifications that are obvious to those skilled in the art and that fall within the scope of the appended claims.
The term "comprising" as used in the claims or specification does not exclude other elements or steps of the corresponding features or processes. The terms "a" or "an" if used in conjunction with a feature do not exclude a plurality of such features. Furthermore, any reference signs in the claims shall not be construed as limiting the scope.
This patent application claims priority from german patent application 102020130774.8, the disclosure of which is incorporated herein by reference.
Description of the reference numerals
1. Test paper box
10. Test paper strip
11. Substrate board
12. Major side of substrate
14. Porous material
15. Photodetector with a light-emitting diode
16. Active area
17. First side of photodetector
18. Second side of photodetector
19. Carrier body
20to 27 conductive wire
28. Major surface of carrier
30. Pixel arrangement
31. Photodetector array
32,33 further pixels
40-47 contact area
50-57 connection point
58. Bonding wire
60,61 additional active area
62,63 additional photodetectors
70. Light source
71. Additional vectors
80. Sample pad
81. Bonding pad
82. Absorbent pad
85. Shell body
86. A first opening
87. A second opening
88. Cavity(s)
89. Electrical contact
90. A third opening
91. Spacing structure
92. Groove(s)
93. Step
94. Protrusions
95. The upper side of the shell
96. The underside of the housing
97. Reflective layer
98. Handle bar
99. Collar ring
100. Monitoring device
101. Equipment shell
102. Control circuit
103. Socket
104. Interface
105. Display device
106. Power supply
107. User interface
108. Spring contact
109. Accommodating structure
110. Light barrier
Distance D
F flow
GND reference potential
INT signal
SCL clock signal
SDA data signal
VCC supply voltage

Claims (20)

1. A test strip cartridge (1) comprising:
a housing (85) defining a first opening (86), the first opening (86) being configured to receive a sample liquid, the housing further defining a second opening (87) and a spacing structure (91), the second opening (87) being configured to provide an optical path into the housing (85),
A carrier (19) comprising at least one photodetector (15), said at least one photodetector (15) being aligned with a second opening (87) of said housing (85),
-a test strip (10) comprising a sample pad (80) aligned with the first opening (86), and at least one active area (16) aligned with the second opening (87) and the at least one photodetector (15), wherein the housing (85) encloses the carrier (19) and the test strip (10) such that the test strip (10) is separated from the carrier (19) by the spacing structure (91) and arranged between the second opening (87) and the carrier (19).
2. The test strip cartridge (1) according to claim 1, wherein the test strip (10) comprises a porous material (14), in particular nitrocellulose, the porous material (14) being configured to transfer a sample liquid from the sample pad (80) to the at least one active area (16), and wherein the at least one active area (16) is provided with a chemical substance that reacts with a composition of the sample liquid.
3. The test strip cartridge (1) according to one of claims 1 to 2, wherein the at least one photodetector (15) is arranged on a side of the carrier (19) facing the test strip (10).
4. A test strip cartridge (1) according to one of claims 1 to 3, further comprising
A third opening (90) of the housing (85),
-electrical contacts (89) of the carrier (19), the electrical contacts (89) being arranged outside the housing (85), outside a third opening (90), and
-electrically conductive wires (20-27) on or in the carrier (19), the electrically conductive wires (20-27) electrically connecting the contact areas (40-47) of the at least one photodetector (15) to electrical contacts (89) outside the third opening (90).
5. The test strip cartridge (1) according to claim 4, wherein the conductive lines (20-27) comprise a power line (20), a reference potential line (21) and at least one bus (22).
6. The test strip cartridge (1) according to one of claims 1 to 5, wherein the at least one photodetector (15) is implemented as a spectral sensor configured to detect light in at least two different wavelength regions, respectively.
7. The test strip cartridge (1) according to one of claims 1 to 6, wherein the inner surface of the housing comprises at least one of a step (93), a groove (92) and/or a protrusion (94) to receive the test strip (10) and the carrier (19) in a predetermined position, thereby providing a positional alignment between the second opening (87), the at least one active area (16) and the at least one photodetector (15).
8. The test strip cartridge (1) according to one of claims 1 to 7, wherein the distance (D) between the at least one active area (16) and the at least one photodetector (15) is 0.3mm to 5mm, or 0.5mm to 3mm.
9. The test strip cartridge (1) according to one of claims 1 to 8, wherein the test strip (10) comprises at least two active areas (16, 60), and wherein the at least one photodetector (15) comprises at least two pixels (30), each pixel being aligned with one of the at least two active areas (16, 60), or a first photodetector (15) being aligned with one of the at least two active areas (15) and a second photodetector (62) being aligned with the other of the at least two active areas (60).
10. The test strip cartridge (1) according to one of claims 1 to 9, wherein the first opening (86) and the second opening (87) are arranged on an upper side (95) of the housing (85), wherein the test strip (10) is arranged between the upper side and the carrier (19).
11. The test strip cartridge (1) according to one of claims 1 to 9, wherein the first opening (86) is arranged on an upper side (95) of the housing (85) and the second opening is arranged on an opposite lower side (96) of the housing (85), wherein the test strip (10) is arranged between the lower side (96) and the carrier (19).
12. The test strip cartridge (1) according to one of claims 1 to 11, wherein the at least one active region (16) is arranged on a side of the test strip (10) facing away from the carrier (19).
13. The test strip cartridge (1) according to one of claims 1 to 11, wherein the at least one active region (16) is arranged on a side of the test strip (10) facing the carrier (19).
14. The test strip cartridge (1) according to one of claims 1 to 13, further comprising a light source (70) arranged on the carrier (19), wherein the light source (70) is configured to emit light towards the at least one active area (16), and the at least one photodetector (15) is configured to detect light reflected from the at least one active area (16).
15. The test strip cartridge (1) according to one of claims 1 to 14, wherein a second opening (87) defined by the housing (85) tapers towards the at least one active area (16) of the test strip (10).
16. The test strip cartridge (1) according to one of claims 1 to 15, wherein a side wall of the second opening (87) defined by the housing (85) is coated with a reflective layer (97).
17. A monitoring device (100), comprising:
Test strip cartridge (1) according to one of claims 1 to 13,
-a light source (70), and
-a control circuit (102) connected to the photodetector (15) and to the light source (70), wherein
The test strip (10) is located between the light source (70) and a carrier (19) comprising the at least one photodetector (15), or wherein the light source (70) is arranged on the carrier (19) of the test strip cartridge (1).
18. The monitoring device (100) according to claim 15, wherein the monitoring device (100) is configured such that the test strip cartridge (1) is selectively insertable into and removable from the monitoring device (100).
19. The monitoring device (100) according to claim 15 or 16, wherein the control circuit (102) is configured to detect whether the test strip cartridge (1) is inserted and to provide an enabling signal when the test strip cartridge (1) is inserted.
20. A method of manufacturing a test strip cartridge (1), comprising:
providing a carrier (19) comprising at least one photodetector (15),
providing a test strip (10) comprising a sample pad (80) and at least one active area (16),
providing a housing (85) defining a first opening (86), the first opening (86) being configured to receive a sample liquid, the housing further defining a second opening (87) and comprising a spacing structure (91), the second opening (87) being configured to provide an optical path into the housing (85),
-assembling the housing (85), the test strip (10) and the carrier (19) such that the housing (85) encloses the carrier (19) and the test strip (10), the test strip (10) being separated from the carrier (19) by the spacing structure (91) and being arranged between the second opening (87) and the carrier (19), wherein the at least one photodetector (15), the at least one active region (16) and the second opening (87) are aligned with each other, and wherein the sample pad (80) is aligned with the first opening (86) of the housing (85).
CN202180066990.7A 2020-11-20 2021-11-18 Test strip box, monitoring equipment and method for manufacturing test strip box Pending CN116235041A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102020130774.8 2020-11-20
DE102020130774 2020-11-20
PCT/EP2021/082137 WO2022106537A1 (en) 2020-11-20 2021-11-18 Test strip cassette, monitoring device and method for fabricating a test strip cassette

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